The U.S. Food and Drug Administration has proposed a new draft guide that would implement tougher procedures for membership on advisory committees.
Veterinarians, physicians and other medical experts with a financial interest in a manufacturer would not be allowed to vote on advisory panels assessing whether drugs, vaccines, devices or other products made by that company are safe and effective.
Financial interests include, but are not limited to, gifts, stock ownership, grants, related research and consulting arrangements.
“FDA is committed to making the advisory committee process more rigorous and transparent so that the public has confidence in the integrity of the recommendations made by its advisory committees,” said Randall Lutter, Ph.D., FDA’s acting deputy commissioner for policy. “The draft guidance document should provide more consistency in the consideration of who is eligible to participate in advisory committee meetings and would simplify the process.”
Currently, the FDA screens all prospective advisory committee participants before each meeting to determine whether the potential for a financial conflict of interest exists. Under law, the FDA may grant a waiver when certain criteria are met, such as when the need for an individual’s expertise outweighs the potential for a conflict of interest.
The new guidance would reduce the likelihood that the process for recommending waivers would vary from meeting to meeting.
The FDA would also tighten its policy for considering eligibility for participation. If someone has disqualifying financial interests whose combined value exceeds $50,000, he or she would generally not be considered for participation in the meeting, regardless of the need for his or her expertise. If the financial interests are $50,000 or less, he or she might be recommended to participate as a non-voting member.
Only individuals with no potential conflicts would be eligible to fully participate in meetings as voting members.
The number of veterinarians or experts as a whole that could potentially be banned from voting remains unclear, a FDA spokeswoman said. And although the FDA doesn’t foresee a large concern with the possibility of having less qualified advisors, plans to recruit representatives are in the works.
The FDA is accepting pubic comments on the proposal until May 21.
For more information, visit www.fda.gov/oc/advisory.